Using Trilaciclib with chemotherapy for non-small cell lung cancer

A Prospective, Single-arm, Exploratory Clinical Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer

This study is testing if adding Trilaciclib to chemotherapy helps people with non-small cell lung cancer have fewer side effects and better treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Taixing People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Taixing, Jiangsu)
• Trial ID: NCT06328049 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of Trilaciclib when used alongside platinum-based chemotherapy in patients with non-small cell lung cancer (NSCLC). It is a single-arm, exploratory study where eligible participants receive Trilaciclib before their first chemotherapy cycle. The study monitors various outcomes, including the incidence of febrile neutropenia, antibiotic use, and treatment delays or dose reductions due to side effects. Blood samples are collected at specified intervals to assess the drug's impact on patient health during treatment.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with advanced non-small cell lung cancer who have not yet started systemic chemotherapy.

Not a fit: Patients with uncontrolled ischemic heart disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and reduce complications for patients undergoing chemotherapy for NSCLC.

How similar studies have performed: While this approach is exploratory, similar studies have shown promise in enhancing chemotherapy safety and efficacy.

Eligibility criteria

Inclusion Criteria:

* Age above 18 years old (including 18 years old)，regardless of gender；
* ECOG-PS score of 0-1,；
* expected survival≥12 weeks；
* There was no tumor deterioration in the 2 weeks prior to study drug treatment.
* Advanced non-small cell lung cancer without systemic chemotherapy.
* At least one tumor lesion with a maximum diameter ≥10 mm (short diameter ≥15 mm if it is a lymph node) that could be measured accurately at baseline according to RECIST1.1 criteria. Baseline tumor imaging was performed within 28 days before the first dose.
* Women of childbearing age should use appropriate contraception and should not breastfeed from screening until 3 months after discontinuation of study treatment.
* Male subjects should use barrier contraception (i.e., condoms) for 3 months from screening until discontinuation of study treatment.
* All subjects voluntarily participated and signed the informed consent form in person.

Exclusion Criteria:

* Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
* stroke or cardio-cerebrovascular event within 6 months before enrollment;
* QTcF interval \> 480msec at screening or \> 500msec for patients with implanted ventricular pacemakers;
* Previous hematopoietic stem cell or bone marrow transplantation;
* Allergy to the study drug or its components;
* Others considered by the investigator to be unsuitable for this study.

Where this trial is running

Taixing, Jiangsu

• Taixing People's Hospital — Taixing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: liu C yang, M.D. — Taixing People's Hospital
• Study coordinator: liu C yang, M.D.

Conditions NSCLC